Phase III SUNLIGHT trial of Lonsurf meets primary endpoint in colorectal cancer
Servier and Taiho Oncology announced the release of data from SUNLIGHT, a pivotal Phase III global trial evaluating the combination of Lonsurf (trifluridine/tipiracil) and Avastin (bevacizumab) in adults with refractory metastatic colorectal cancer (mCRC), demonstrating that the trial met its primary endpoint of overall survival (OS)
The SUNLIGHT trial investigated the efficacy and safety of trifluridine/tipiracil plus bevacizumab versus trifluridine/tipiracil alone in patients with refractory mCRC following disease progression or intolerance on two prior chemotherapy regimens. Results from the main analysis demonstrated that the investigational combination provided a statistically significant and a clinically meaningful improvement in OS of 3.3 months compared to trifluridine/tipiracil alone (10.8 months vs. 7.5 months, hazard ratio [HR]: 0.61, 95% confidence interval [CI]: 0.49-0.77, p<0.001).
This improvement in OS represents a 39% reduction in the risk of death in patients with refractory mCRC. Regarding the key secondary endpoint, there was a statistically significant improvement for the trifluridine/tipiracil plus bevacizumab combination versus trifluridine/tipiracil alone in progression-free survival (PFS) (5.6 months vs. 2.4 months, HR: 0.44, 95% CI: 0.36-0.54, p<0.001). side effects were as expected based on the known profile of each treatment and well managed. these data will be shared during an oral presentation (abstract #392020) on january 21, 2023 at the american society of clinical oncology gastrointestinal cancers symposium (asco gi) in san francisco.
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